Johannes Lammer , 1 , Katarina Malagari 2 , Thomas Vogl 3 , Frank Pilleul 4 , Alban Denys 5 , Anthony Watkinson 6 , Michael Pitton 7 , Geraldine Sergent 8 , Thomas Pfammatter 9 , Sylvain Terraz 10 , Yves Benhamou 11 , Yves Avajon 12 , Thomas Gruenberger 13 , Maria Pomoni 2 , Herbert Langenberger 1 , Marcus Schuchmann 7 , Jerome Dumortier 4 , Christian Mueller 13 , Patrick Chevallier 14 , Riccardo Lencioni 15 , On Behalf of the PRECISION V Investigators
12 November 2009
Transcatheter arterial chemoembolization (TACE) offers a survival benefit to patients with intermediate hepatocellular carcinoma (HCC). A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge—conventional TACE. Recently, a drug-eluting bead (DC Bead ®) has been developed to enhance tumor drug delivery and reduce systemic availability. This randomized trial compares conventional TACE (cTACE) with TACE with DC Bead for the treatment of cirrhotic patients with HCC. Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and/or multinodular, unresectable, N0, M0 HCCs were randomized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin. Randomization was stratified according to Child-Pugh status (A/B), performance status (ECOG 0/1), bilobar disease (yes/no), and prior curative treatment (yes/no). The primary endpoint was tumor response (EASL) at 6 months following independent, blinded review of MRI studies. The drug-eluting bead group showed higher rates of complete response, objective response, and disease control compared with the cTACE group (27% vs. 22%, 52% vs. 44%, and 63% vs. 52%, respectively). The hypothesis of superiority was not met (one-sided P = 0.11). However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response ( P = 0.038) compared to cTACE. DC Bead was associated with improved tolerability, with a significant reduction in serious liver toxicity ( P < 0.001) and a significantly lower rate of doxorubicin-related side effects ( P = 0.0001). TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease.